Nail fixation of unstable trochanteric fractures with or without cement augmentation: A cost-utility analysis in the United States: Cost-utility of cement augmentation.

OBJECTIVES: Recent clinical studies have shown favorable outcomes for cement augmentation for fixation of trochanteric fracture. We assessed the cost-utility of cement augmentation for fixation of closed unstable trochanteric fractures from the US payer's perspective. METHODS: The cost-utility model comprised a decision tree to simulate clinical events over 1 year after the index fixation surgery, and a Markov model to extrapolate clinical events over patients' lifetime, using a cohort of 1,000 patients with demographic and clinical characteristics similar to that of a published randomized controlled trial (age ≥75 years, 83 % female). Model outputs were discounted costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) over a lifetime. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainty on results. RESULTS: Fixation with augmentation reduced per-patient costs by $754.8 and had similar per-patient QALYs, compared to fixation without augmentation, resulting in an ICER of -$130,765/QALY. The ICER was most sensitive to the utility of revision surgery, mortality risk ratio after the second revision surgery, mortality risk ratio after successful index surgery, and mortality rate in the decision tree model. The probability that fixation with augmentation was cost-effective compared with no augmentation was 63.4 %, 58.2 %, and 56.4 %, given a maximum acceptable ceiling ratio of $50,000, $100,000, and $150,000 per QALY gained, respectively. CONCLUSION: Fixation with cement augmentation was the dominant strategy, driven mainly by reduced costs. These results may support surgeons in evidence-based clinical decision making and may be informative for policy makers regarding coverage and reimbursement.

Cost-utility of VISITAG SURPOINT in catheter ablation of atrial fibrillation.

BACKGROUND: Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. METHODS: We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. RESULTS: CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CONCLUSIONS: CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.

Budget Impact Analysis of Minimally Invasive versus Open Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Disease: A European Hospital Perspective.

Purpose: When traditional therapies fail to provide relief from debilitating lower back pain, surgeries such as transforaminal lumbar interbody fusion (TLIF) may be required. This budget impact analysis (BIA) compared minimally-invasive (MI)-TLIF versus open (O)-TLIF for single-level fusion from an Italian hospital perspective. Methods: The BIA compared costs of 100 MI-TLIF and 100 O-TLIF procedures from an Italian hospital perspective over a one-year time horizon. The base case included costs for length of hospital stay (LOS), blood loss, and sterilizing surgical trays. The scenario analysis also included operating room (OR) time and complication costs. Base case inputs were from the Miller et al meta-analysis; scenario analysis inputs were from the Hammad et al meta-analysis. The device costs for MI-TLIF and O-TLIF procedures were from Italian tender prices for Viper Prime™ System and Expedium™ Spine System, respectively. Results: Base case deterministic analysis results showed cost savings of €207,370 for MI-TLIF compared with O-TLIF. MI-TLIF costs were lower for LOS (€215,277), transfusion for blood loss (€16,881), and surgical tray sterilization (€28,232), whereas device costs were lower for O-TLIF (€53,020). The probabilistic result was similar, with MI-TLIF resulting in savings of €211,026 (95% credible interval [CR]: €208,725 - €213,327). All 1000 base case probabilistic sensitivity analysis runs were cost saving. Deterministic scenario analysis results showed cost savings of €166,719 for MI-TLIF. MI-TLIF costs were lower for LOS (€190,813), transfusion for blood loss (€16,881), surgical tray sterilization (€28,232), and complications (€2076), whereas O-TLIF costs were lower for OR time (€18,263) and devices used (€53,020). Conclusion: Despite the increase incremental cost for medical device innovation and OR time, this study demonstrates the economic savings of MI-TLIF compared to O-TLIF from a European hospital perspective. The findings will be useful to policy and hospital decision makers in assessing purchasing, funding and reimbursement decisions.

Cost-Effectiveness of Bariatric Surgery in Tunisia.

Purpose: Obesity is a growing global issue with evidence linking it to an increase in loss of disease-free years, reduced quality of life, increased mortality, and additional economic burden. This study sought to establish the cost-effectiveness of gastric bypass and sleeve gastrectomy, compared to conventional therapy in patients with obesity, from a Tunisian healthcare payor perspective. Patients and Methods: A Markov model compared lifetime costs and outcomes of bariatric surgery with conventional treatment among patients with body mass index (BMI) ≥ 40 kg/m2, BMI ≥ 35 kg/m2 with obesity-related co-morbidities (Group 1), or BMI ≥ 35 kg/m2 with type 2 diabetes mellitus (T2DM) (Group 2). Inputs were sourced from the Tunisian Health Examination Survey, local clinician data and literature sources. Health states were associated with different cost and utility decrements. Changes in body mass index, systolic blood pressure, lipid ratio and diabetes remission rates were modelled on a yearly basis. The incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs) and net monetary benefit (NMB) were key outcomes. Sensitivity and scenario analyses were performed to test the model's robustness. Results: The model showed that the benefits of bariatric surgery were favorable compared to conventional treatment, with an ICER of 1844 TND/QALY in Group 1 patients and 2413 TND/QALY in Group 2 patients. Bariatric surgery resulted in a QALY gain of 3.26 per patient in Group 1 and a gain of 1.77 per patient in Group 2. At a willingness to pay threshold of 31,379 TND/QALY, the incremental NMB was 96,251 TND and 51,123 TND for Group 1 and Group 2, respectively. Conclusion: From the Tunisian healthcare payor perspective, bariatric surgery is cost-effective for patients with obesity and those with T2DM and obesity-related comorbidities. These findings may have impact on future decision-making on funding and reimbursement of bariatric surgery in Tunisia.

Economic and Health Value of Delaying Atrial Fibrillation Progression Using Radiofrequency Catheter Ablation.

BACKGROUND: Radiofrequency catheter ablation (RFCA) is an established treatment for atrial fibrillation (AF) refractory to antiarrhythmic drugs. The economic value of RFCA in delaying disease progression has not been quantified. METHODS: An individual-level, state-transition health economic model estimated the impact of delayed AF progression using RFCA versus antiarrhythmic drug treatment for a hypothetical sample of patients with paroxysmal AF. The model incorporated the lifetime risk of progression from paroxysmal AF to persistent AF, informed by data from the ATTEST (Atrial Fibrillation Progression Trial). The incremental effect of RFCA on disease progression was modeled over a 5-year duration. Annual crossover rates were also included for patients in the antiarrhythmic drug group to mirror clinical practice. Estimates of discounted costs and quality-adjusted life years asssociated with health care utilization, clinical outcomes, and complications were projected over patients' lifetimes. RESULTS: From the payer's perspective, RFCA was superior to antiarrhythmic drug treatment with an estimated mean net monetary benefit per patient of $8516 ($148-$16 681), driven by reduced health care utilization, cost, and improved quality-adjusted life years. RFCA reduced mean (95% CI) per-patient costs by $73 (-$2700 to $2200), increased mean quality-adjusted life years by 0.084 (0.0-0.17) and decreased the mean number of cardiovascular-related health care encounters by 24%. CONCLUSIONS: RFCA is a dominant (less costly and more effective) treatment strategy for patients with AF, especially those with early AF for whom RFCA could delay progression to advanced AF. Increased utilization of RFCA-particularly among patients earlier in their disease progression-may provide clinical and economic benefits.

Outcomes of surgical versus nonsurgical treatment for multiple rib fractures: A US hospital matched cohort database analysis.

BACKGROUND: Treatment for multiple rib fractures includes surgical stabilization of rib fractures (SSRF) or nonoperative management (NOM). Meta-analyses have demonstrated that SSRF results in faster recovery and lower long-term complication rates versus NOM. Our study evaluated postoperative outcomes for multiple rib fracture patients following SSRF versus NOM in a real-world, all-comer study design. METHODS: Multiple rib fracture patients with inpatient admissions in the PREMIER hospital database from October 1, 2015, to September 30, 2020, were identified. Outcomes included discharge disposition, and 3- and 12-month lung-related readmissions. Demographics, comorbidities, concurrent injuries at index, Abbreviated Injury Scale and Injury Severity Scores, and provider characteristics were determined for all patients. Patients were excluded from the cohort if they had a thorax Abbreviated Injury Scale score of <2 (low severity patient) or a Glasgow Coma Scale score of ≤8 (extreme high severity patient). Stratum matching between SSRF and NOM patients was performed using fine stratification and weighting so that all patient data were kept in the final analysis. Outcomes were analyzed using generalized linear models with quasinormal distribution and logit links. RESULTS: A total of 203,450 patients were included, of which 200,580 were treated with NOM and 2,870 with SSRF. Compared to NOM, patients with SSRF had higher rates of home discharge (62% SSRF vs. 58% NOM) and lower rates of lung-related readmissions (3 months, 3.1% SSRF vs. 4.0% NOM; 12 months, 6.2% SSRF vs. 7.6% NOM). The odds ratio (OR) for home or home health discharge in patients with SSRF versus NOM was 1.166 (95% confidence interval [CI], 1.073-1.266; p = 0.0002). Similarly, ORs for lung-related readmission at 3- and 12-month were statistically lower in the patients treated with SSRF versus NOM (OR [3 months], 0.764 [95% CI, 0.606-0.963]; p = 0.0227 and OR [12 months], 0.799 [95% CI, 0.657-0.971]; p = 0.0245). CONCLUSION: Surgical stabilization of rib fractures results in greater odds of home discharge and lower rates of lung-related readmissions compared with NOM at 12 months of follow-up. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Adopting a portfolio of ultrasonic and advanced bipolar electrosurgery devices from a single manufacturer compared to currently used ultrasonic and advanced bipolar devices: a probabilistic budget impact analysis from a Spanish hospital perspective.

AIMS: Advanced energy devices are commonly used in electrosurgery, including ultrasonic and advanced bipolar (ABP) devices. Smoke evacuation and reusable dispersive electrodes are also utilized during electrosurgery to improve staff and patient safety. This study assessed the budget impact of adopting a portfolio of Ethicon energy devices compared to devices from other manufacturers from a Spanish hospital perspective. METHODS: The main analysis compared the Ethicon advanced energy device portfolio (ultrasonic and ABP devices) to Non-Ethicon advanced energy devices. It was assumed that 4,000 procedures using one advanced energy device each were performed annually, and the cost impact of operating room time, length of stay, and transfusions were considered. A probabilistic budget impact analysis with 10,000 iterations was conducted for generalizability to other hospitals in Spain and Europe. Secondary analysis assessed whether cost savings from the Ethicon advanced energy device portfolio could offset costs of adopting smoke evacuation and reusable dispersive electrodes (Full Ethicon energy portfolio). RESULTS: In the main analysis, the annual budget impact of introducing the Ethicon advanced energy device portfolio was cost saving in 79.8% of probabilistic iterations (mean: -€945,214; 95% credible interval [CrI]: -€3,242,710; €1,285,942) with a mean budget impact per procedure of -€236 (95% CrI: -€811; €321). In the secondary analysis, adding smoke evacuation and reusable dispersive electrodes was still cost saving in 75.3% of iterations compared to Non-Ethicon advanced energy devices (mean: -€778,208; 95% CrI: -€3,075,086; €1,464,728) with a mean budget impact per procedure of -€97 (95% CrI: -€384; €183). Savings resulted from differences in operating room time, length of hospital stay, and volume of disposable electrodes. CONCLUSIONS: Adopting Ethicon advanced energy devices demonstrated economic benefits compared to non-Ethicon devices. Introducing the advanced portfolio may improve surgical care quality and the full portfolio was cost saving while improving OR safety for staff and patients.

This study created an economic model to calculate whether using modern electrical surgical tools with features to make cutting tissue and stopping bleeding faster and easier could save Spanish hospitals money. The electrical surgery tools from one manufacturer were compared to those from various other companies. Differences in how long surgery took to perform, how long patients stayed in hospital after their surgery, and how many blood transfusions they needed were considered in the model. The model was tested 10,000 times with random changes in the costs and settings used to be surer about the range of possible results. The results showed the devices from one manufacturer could save a Spanish hospital money in almost 80% of model runs and that savings worked out to €236 per surgery. In another analysis, savings were enough to cover the cost of introducing safety devices to remove surgical smoke from the operating room and reusable patient grounding electrodes that prevent some injuries potentially caused by small sticky electrodes. In conclusion, the model showed that Spanish hospitals may be able to save money by switching to the modern electrical surgery tools from Ethicon.

Healthcare resource use and costs related to surgical infections of tibial fractures in a Spanish cohort.

Surgical site infection constitutes a serious complication in the healing process of bone fractures and has been associated with increases in medical resource use and healthcare costs. This study evaluates the economic impact of surgical site infection in tibial fractures in a Spanish cohort. It is a retrospective, single-centre, comparative cohort study of patients with tibial fractures with longitudinal follow-up for up to 18 months post-surgery. Included patients (n = 325) were adults, with tibial fracture, either isolated or polyfracture, or polytrauma with an Injury Severity Score >15. Patients had been surgically treated within 30 days of the tibial fracture by external or internal fixation, or external followed by internal fixation. Most patients (84.9%) had an American Society of Anaesthesiology score of 1-2. 20% of the patients had one open tibial fracture, 12.3% had polytrauma, and 20% had multiple fractures. Most patients were treated with a nail (41.8%) or a plate (33.8%). 56 patients (17.2%) developed surgical site infection. Patients with infection had significantly higher hospital length of stay (34.9 vs 12.0 days; p<0.001; +191%), readmissions (1.21 vs 0.25; p<0.001; +380%) and mean operating theatre time (499 vs 219 min; p<0.001; +128%) than patients without infection. Mean length of stay in intensive care did not significantly increase with infection (2.8 vs 1.7 days; p = 0.25). Total in-hospital costs for patients with infection increased from €7,607 to €17,538 (p<0.001; +131%). Overall, infections were associated with significantly increased healthcare resource use and costs. Preventive strategies to avoid infections could lead to substantial cost savings.

Improving perioperative management of surgical sets for trauma surgeries: the 4S approach.

BACKGROUND: The perioperative management of the surgical instruments and implants that comprise sets for trauma surgeries has been identified as a complex and resource-intensive activity due to non-standardized inventories, redundant surgical instruments and unnecessary sterilization cycles. The 4S Intelligent Trauma Care program aims to improve perioperative management and thereby reduce environmental impact by utilizing standardized inventories, a sterile implant portfolio, a barcode that enables a digital safety certification, and a digitized restocking service. OBJECTIVE: The objective of this study was to investigate the impact of the introduction of the 4S program for the management of surgical sets in open reduction internal fixation (ORIF) trauma surgeries. METHODS: This was a single-center, quality improvement study of ORIF trauma surgeries, comparing the current practice (30 procedures) to the procedure following the introduction of the 4S program (30 procedures). The primary outcome was the proportion of procedures requiring only one sterilization cycle. Secondary outcomes were the number of sterilization cycles per procedure, set processing time across departments, total set processing costs, number of missing or damaged implants, number of cleaning cycles per procedure, time taken to assemble containers for sterilization, number of containers entering the autoclave per procedure, environmental impact, number of baskets entering the cleaning machine per procedure, and staff satisfaction. RESULTS: Introduction of the 4S program resulted in a reduction in the mean number of sterilization cycles required from 2.1 to 1.0 (p < 0.001). In the current practice, only 30.0% of procedure sets were sterilized within one cycle, compared to 100.0% following introduction of the 4S program (p < 0.001). A reduction in the mean set processing time of 24.1% in the OR and 35.3% in the sterilization department was observed. Mean set processing costs for the current practice were €81.23, compared to €50.30 following introduction of the 4S program. Furthermore, following the introduction of the 4S program, procedures were associated with significant reductions in water and electricity usage, and increased staff satisfaction. CONCLUSIONS: This quality improvement study demonstrates the substantial time and cost savings, positive environmental impact and staff satisfaction that could be achieved by streamlining surgical set management through the 4S program. To our knowledge, this is the first study of this type and our findings may be instructive to other hospitals and surgical specialties.

Cost-Effectiveness of Cement Augmentation Versus No Augmentation for the Fixation of Unstable Trochanteric Fractures.

BACKGROUND: A previous randomized controlled trial (RCT) demonstrated a trend toward a reduced risk of implant-related revision surgery following fixation with use of a Proximal Femoral Nail Antirotation (PFNA) with TRAUMACEM V+ Injectable Bone Cement augmentation versus no augmentation in patients with unstable trochanteric fractures. To determine whether this reduced risk may result in long-term cost savings, the present study assessed the cost-effectiveness of TRAUMACEM V+ cement augmentation versus no augmentation for the fixation of unstable trochanteric fractures from the German health-care payer's perspective. METHODS: The cost-effectiveness model comprised 2 stages: a decision tree simulating clinical events, costs, and utilities during the first year after the index procedure and a Markov model extrapolating clinical events, costs, and utilities over the patient's lifetime. Sources of model parameters included the previous RCT, current literature, and administrative claims data. Outcome measures were incremental costs (in 2020 Euros), incremental quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Model uncertainty was assessed with deterministic and probabilistic sensitivity analyses. RESULTS: The base-case analysis showed that fixation with cement augmentation was the dominant strategy as it was associated with cost savings (€50.3/patient) and QALY gains (0.01 QALY/patient). Major influential parameters for the ICER were the utility of revision, rates of revision surgery within the first year after fixation surgery, and the costs of augmentation and revision surgery. Probabilistic sensitivity analyses demonstrated that estimates of cost savings were more robust than those of increased QALYs (66.4% versus 52.7% of the simulations). For a range of willingness-to-pay thresholds from €0 to €50,000, the probability of fixation with cement augmentation being cost-effective versus no augmentation remained above 50%. CONCLUSIONS: Fixation with use of cement augmentation dominated fixation with no augmentation for unstable trochanteric fractures, resulting in cost savings and QALY gains. Given the input parameter uncertainties, future analyses are warranted when long-term costs and effectiveness data for cement augmentation are available. LEVEL OF EVIDENCE: Economic and Decision Analysis Level II . See Instructions for Authors for a complete description of levels of evidence.

Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis.

INTRODUCTION: Atrial fibrillation (AF) is a major cause of stroke. Anticoagulants substantially reduce risk of stroke but are also associated with an increased risk of bleeding. Because of that, many patients do not receive anticoagulants, particularly patients at risk of falls. This systematic review and meta-analysis aims to compare anticoagulant treatment options for the management of atrial fibrillation patients at risk of falls or with a history of falls. METHODS: We conducted a PRISMA systematic review (until March 2022), including studies evaluating safety and efficacy of different anticoagulants (vitamin K antagonist [VKA] versus non-vitamin K antagonist oral anticoagulant [NOAC]). Outcomes were ischemic stroke, major bleeding, intracranial hemorrhage, hemorrhagic stroke, myocardial infarction, gastrointestinal bleeding, cardiovascular and all-cause mortality. A multilevel meta-analysis was conducted adjusting for clustering effects within studies examining more than one effect size. RESULTS: A total of 919 articles were identified, 848 after removing duplicates. The full text of 155 were screened and 10 articles were retained for final quantitative synthesis. Risk of bias was moderate to serious for the included studies. In meta-analysis, NOACs were associated with superior effectiveness compared with VKA for ischemic stroke/systemic embolism (hazard ratio [HR] 0.82, 95% confidence interval [CI] 0.69-0.98; p < 0.05) and safety (HR 0.53, 95% CI 0.40-0.71; p < 0.05) for intracranial hemorrhage. There were no differences in other outcomes. CONCLUSION: NOACs were associated with less intracranial hemorrhages and ischemic strokes/systemic embolisms than VKAs in AF patients at risk of falls. These findings suggesting preferred use of NOACs over VKAs have clinical implications for physicians, patients and policy makers.

Treatment patterns and clinical and economic burden of hip dislocation following primary total hip arthroplasty in England.

AIMS: The aim of this study was to estimate the clinical and economic burden of dislocation following primary total hip arthroplasty (THA) in England. METHODS: This retrospective evaluation used data from the UK Clinical Practice Research Datalink database. Patients were eligible if they underwent a primary THA (index date) and had medical records available 90 days pre-index and 180 days post-index. Bilateral THAs were excluded. Healthcare costs and resource use were evaluated over two years. Changes (pre- vs post-THA) in generic quality of life (QoL) and joint-specific disability were evaluated. Propensity score matching controlled for baseline differences between patients with and without THA dislocation. RESULTS: Among 13,044 patients (mean age 69.2 years (SD 11.4), 60.9% female), 191 (1.5%) had THA dislocation. Two-year median direct medical costs were £15,333 (interquartile range (IQR) 14,437 to 16,156) higher for patients with THA dislocation. Patients underwent revision surgery after a mean of 1.5 dislocations (1 to 5). Two-year costs increased to £54,088 (IQR 34,126 to 59,117) for patients with multiple closed reductions and a revision procedure. On average, patients with dislocation had greater healthcare resource use and less improvement in EuroQol five-dimension index (mean 0.24 (SD 0.35) vs 0.44 (SD 0.35); p < 0.001) and visual analogue scale (0.95 vs 8.85; p = 0.038) scores, and Oxford Hip Scores (12.93 vs 21.19; p < 0.001). CONCLUSION: The cost, resource use, and QoL burden of THA dislocation in England are substantial. Further research is required to understand optimal timing of revision after dislocation, with regard to cost-effectiveness and impact on QoL. Cite this article: Bone Joint J 2022;104-B(7):811-819.

Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective.

BACKGROUND: Mastectomy or breast conserving surgery, both with axillary lymph node dissection, are common treatments for early-stage breast cancer. Monopolar electrocautery is typically used for both procedures, despite evidence of improved clinical outcomes with HARMONIC FOCUS™+. This analysis evaluated the budget impact of adopting HARMONIC FOCUS™+ versus monopolar electrocautery for patients undergoing these procedures from an Italian hospital perspective. METHODS: Total costs for an annual caseload of 100 patients undergoing mastectomy or breast conserving surgery, with axillary lymph node dissection, with either the intervention or comparator were calculated. Italian clinical and cost input data were utilised. The analysis included costs for the device, operating room time, postoperative length of stay, treating seroma and managing postoperative chest wall drainage. Deterministic and probabilistic sensitivity analyses assessed uncertainty of model input values. Two scenario analyses investigated the impact of conservative estimates of postoperative length of stay reduction and daily hospital cost on the simulated cost difference. RESULTS: HARMONIC FOCUS™+ achieves annual savings of EUR 100,043 compared with monopolar electrocautery, derived from lower costs for operating room time, postoperative length of stay and seroma and postoperative chest wall drainage management, offsetting the incremental device cost increase (EUR 43,268). Cost savings are maintained in scenario analyses and across all variations in parameters in deterministic sensitivity analysis, with postoperative hospital stay costs being key drivers of budget impact. The mean (interquartile range) cost savings with HARMONIC FOCUS™+ versus monopolar electrocautery in probabilistic sensitivity analysis are EUR 101,637 (EUR 64,390-137,093) with a 98% probability of being cost saving. CONCLUSIONS: The intervention demonstrates robust cost savings compared with monopolar electrocautery for mastectomy or breast conserving surgery, with axillary lymph node dissection, in an Italian hospital setting, and improved clinical and resource outcomes. These findings, with other clinical and cost analyses, support HARMONIC FOCUS™+ use in this setting.

The management of anticoagulants in patients with atrial fibrillation and history of falls or risk of falls: protocol for a systematic review and meta-analysis.

BACKGROUND: Atrial fibrillation affects an estimated 33 million individuals worldwide and is a major cause of stroke, heart failure, and death. Anticoagulants substantially reduce the risk of stroke but are also associated with an increased risk of bleeding and especially intracranial hemorrhage which is the most concerning complication. Because of this, many patients are not offered anticoagulants, particularly patients at risk of falls or with a history of falls. It is unclear what anticoagulant treatment these patients should be offered. The Liverpool AF-Falls project aims to investigate this area, and this protocol for a systematic review and meta-analysis aims to define what is the most appropriate anticoagulant treatment option for the management of atrial fibrillation patients at risk of falls or with a history of falls. METHODS: This systematic review and meta-analysis will include randomized and non-randomized studies evaluating the safety and efficacy of different anticoagulant treatments (vitamin K antagonist and non-vitamin K antagonist oral anti-coagulant). Bibliographic databases (Cochrane Central Register of Controlled Trials, CINAHL, ClinicalTrials.gov , Embase, MEDLINE, Scopus and Web of Science) will be searched according to a pre-specified search strategy. Titles, abstracts, and full texts will be assessed by two independent reviewers and disagreements resolved with a third independent reviewer. The Cochrane Risk of Bias tool 2 (RoB 2) will be used to assess the risk of bias in randomized trials, and the Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool will be used for non-randomized studies. A pairwise meta-analysis based on the fixed and random-effects models will be conducted. Publication bias will be evaluated with a funnel plot and Egger's test. Heterogeneity will be assessed with the I2 statistic. If conditions for indirect comparison are met and sufficient data are available, a network meta-analysis will be conducted using frequentist and Bayesian methodologies. DISCUSSION: This review will be the first to summarize direct and indirect evidence on the safety and efficacy of anticoagulant treatments in atrial fibrillation patients at risk of falls or with a history of falls. The findings will be important to patients, clinicians, and health policy-makers to inform best practices in the use of these treatments. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registry number: CRD42020201086.

In-hospital economic burden of anastomotic leakage after colorectal anastomosis surgery: a real-world cost analysis in Italy.

BACKGROUND: Anastomotic leakage (AL) is a severe complication of colorectal surgery. We aimed to quantify inpatient costs and key cost contributors associated with AL in a single Italian center. RESEARCH DESIGN AND METHODS: Electronic records for adults who had undergone colorectal surgery with anastomosis (January 2015 - December 2016), were retrospectively reviewed. Patients with AL were identified using clinical signs and/or imaging findings and/or intraoperative findings. Available data included patient, clinical, and procedural characteristics, healthcare resource utilization, and inpatient costs. Multivariate models were used to adjust for potential confounders. RESULTS: AL occurred in 12.3% of patients (N = 317). Mean adjusted inpatient cost was 108% higher (p < 0.001) for patients with AL versus no AL (€14,711; 95% CI: 12,113; 17,866 versus €7,089; 95% CI: 6,623; 7,587). Key cost contributors were ward stay, disposables, operating room, and hospital consultations. Mean losses (reimbursement minus costs) were €2,041/patient with AL. AL extended mean length of stay by 9 days and increased odds of reoperation and ICU stay (all p < 0.001). CONCLUSIONS: Patients with AL place considerable economic and resource burden on healthcare systems and hospital reimbursement rates do not cover treatment costs. This study highlights an unmet need for novel techniques to reduce the burden of AL.

Cost-effectiveness of bariatric and metabolic surgery, and implications of COVID-19 in the United Kingdom.

BACKGROUND: People living with obesity have been among those most disproportionately impacted by the COVID-19 pandemic, highlighting the urgent need for increased provision of bariatric and metabolic surgery (BMS). OBJECTIVES: To evaluate the possible clinical and economic benefits of BMS compared with nonsurgical treatment options in the UK, considering the broader impact that COVID-19 has on people living with obesity. SETTING: Single-payer healthcare system (National Health Service, England). METHODS: A Markov model compared lifetime costs and outcomes of BMS and conventional treatment among patients with body mass index (BMI) ≥ 40 kg/m2, BMI ≥ 35 kg/m2 with obesity-related co-morbidities (Group A), or BMI ≥ 35 kg/m2 with type 2 diabetes (T2D; Group B). Inputs were sourced from clinical audit data and literature sources; direct and indirect costs were considered. Model outputs included costs and quality-adjusted life years (QALYs). Scenario analyses whereby patients experienced COVID-19 infection, BMS was delayed by five years, and BMS patients underwent endoscopy were conducted. RESULTS: In both groups, BMS was dominant versus conventional treatment, at a willingness-to-pay threshold of £25,000/QALY. When COVID-19 infections were considered, BMS remained dominant and, across 1000 patients, prevented 117 deaths, 124 hospitalizations, and 161 intensive care unit admissions in Group A, and 64 deaths, 65 hospitalizations, and 90 intensive care unit admissions in Group B. Delaying BMS by 5 years resulted in higher costs and lower QALYs in both groups compared with not delaying treatment. CONCLUSION: Increased provision of BMS would be expected to reduce COVID-19-related morbidity and mortality, as well as obesity-related co-morbidities, ultimately reducing the clinical and economic burden of obesity.

Economic Analysis of Leak Complications in Anastomoses Performed with Powered versus Manual Circular Staplers in Left-Sided Colorectal Resections: A US-Based Cost Analysis.

PURPOSE: To estimate the cost impact of using the ECHELON CIRCULAR™ Powered Stapler (ECP) compared with manual circular staplers (standard of care, SOC) among patients undergoing colectomy procedures that involve left-sided anastomosis. METHODS: A US hospital-based budget impact model was developed to estimate the impact of ECP in reducing the surgical complication of anastomotic leak. The incremental acquisition cost of ECP vs SOC was compared to the net potential savings from reduced complication costs. The model was based on complication rates from a recently published matching-adjusted indirect comparison (MAIC) that compared clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective SOC control cohort from a real-world clinical practice population. The model assessed total cost, average length of stay (LOS), proportion of patients with a non-home discharge, and all-cause readmission. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were conducted to evaluate the robustness of the model assumptions and inputs. RESULTS: Despite a higher device cost of $412 for ECP compared with $298 for a manual stapler, annual savings due to avoided complications with ECP was $53,987 for anastomotic leak, assuming 100 procedures per year with each type of circular stapler. ECP also helped to avoid 27 LOS days, 0.38 readmissions and 0.22 non-home discharges. Sensitivity analyses around potential drivers of costs established the robustness of economic savings with the use of ECP - with annual savings being most impacted by the probability of anastomotic leak complication in the DSA. CONCLUSION: This model demonstrates that among patients undergoing left-sided colectomy procedures, the incremental cost of using the ECHELON CIRCULAR™ Powered Stapler instead of a manual circular stapler was offset by the savings from lowered incidence and cost of management of anastomotic leaks in the hospital setting.

The economic burden of infections following intramedullary nailing for a tibial shaft fracture in England.

OBJECTIVES: Determine the impact of infections on direct costs and healthcare resource use in England for patients undergoing intramedullary nailing (IMN) for tibial shaft fractures. DESIGN: Non-concurrent cohort based on retrospectively collected data with 2-year follow-up. SETTING: England. PARTICIPANTS: The study population included adult patients (≥18 years) in England with a diagnosis of tibial shaft fracture (International Classification of Diseases-10, S822) in the inpatient setting between May 2003 and June 2017 followed by a procedure for IMN for tibial shaft fracture within 30 days. Patient data were derived from the Clinical Practice Research Datalink linked to National Health Service Hospital Episode Statistics datasets. PRIMARY INDEPENDENT VARIABLE: Infection. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was total inpatient costs from index stay admission through 1 year of follow-up. Secondary outcome included cumulative total healthcare costs, and resource utilisation at 30 days, 90 days, 1 year and 2 years. RESULTS: Overall, 805 patients met the inclusion criteria. At index inpatient stay, 3.7% had a post-IMN infection, rising to 11.7% at 1 year. One-year inpatient costs were 80% higher for patients with infection (p<0.001). Total costs were estimated to be £14 756 (95% CI £13 123 to £16 593) for patients with infection versus £8279 (95% CI £7946 to £8626). Length of stay (LOS), readmission and reoperation were the key drivers of healthcare costs (all p<0.001). After adjustment, LOS was higher by 109% (95% CI 62% to 169%), from 10.5 days to 21.9 days, for patients with infection. The odds of being readmitted or requiring reoperation were higher by 5.18 times (95% CI 3.01 to 9.13) and 2.47 times (95% CI 1.48 to 4.09), respectively, for patients with infection versus those without infection. CONCLUSIONS: Post-IMN infection significantly increases inpatient costs, LOS, readmissions and reoperations associated with tibial fracture fixation. Healthcare burden could be reduced through novel surgical site infection prevention strategies.

Perception of quality of life in people experiencing or having experienced a Clostridioides difficile infection: a US population survey.

BACKGROUND: Although the incidence, severity and mortality of Clostridioides (Clostridium) difficile infection (CDI) have been increasing, patients' quality of life changes resulting from CDI have not been studied thoroughly. This study aimed at exploring the consequences of CDI on quality of life through patients' perspective. METHODS: An observational, cross-sectional study involving 350 participants with a self-reported CDI diagnosis was conducted through an online self-administered survey. Participants were grouped into those who had active disease ("Current CDI") and those who had a history of CDI ("Past CDI"). RESULTS: One hundred fifteen participants (33%) reported Current CDI and 235 (67%) reported Past CDI. A large majority of participants admitted that their daily activities were impacted by the infection (93.9% and 64.7% of Current and Past CDI respondents respectively, p < 0.05). Physical and psychological consequences of CDI were experienced by 63.5% and 66.1% of participants with active CDI. Despite the infection being cleared, these consequences were still frequently experienced in Past CDI cohort with similar rates (reported by 73.2% of respondents for both, physical consequences p = 0.08; psychological consequences p = 0.21). After the infection, 56.6% of respondents noted that post-CDI symptoms remained; 40.9% believed they would never get rid of them. CONCLUSIONS: While the societal burden of CDI is well described in the literature, our study is one of the first aimed at understanding the major burden of CDI on quality of life. Our results highlight the long-lasting nature of CDI and further reinforce the need for enhanced therapeutics in the prevention and treatment of this devastating infection.

Comparative Analysis Investigating the Impact of Implant Design on Hospital Length of Stay and Discharge Destination in a Dutch Hospital With an Established Enhanced Recovery Program.

BACKGROUND: Global demand for total knee arthroplasty (TKA) is increasing, driven by an aging and increasingly overweight patient population, culminating in higher healthcare costs. In the Netherlands, the number of TKA surgeries performed annually increased from 21,000 in 2010 to 29,000 in 2017. This study aimed to assess the impact of implant design on hospital length of stay (LOS), surgery time, and discharge destination (home vs a rehabilitation center) in a Dutch hospital with an established enhanced recovery program and short baseline LOS. METHODS: A retrospective review of consecutive adult patients who underwent primary TKA in a Dutch hospital between 2015 and 2017 using either the comparator device or the control device. RESULTS: A total of 200 patients were enrolled in the study (100 per group). Patients who received a comparator device had a significantly shorter LOS (adjusted mean 2.76 days; 95% confidence interval [CI]: 2.45, 3.11) vs the control group (adjusted mean 3.43 days; 95% CI: 3.08, 3.81; P < .01). The proportion of patients discharged to a rehabilitation center, instead of home, was also significantly lower in the comparator device group (adjusted 4.4%; 95% CI: 1.8, 10.7 vs adjusted 11.4%; 95% CI: 6.0, 20.6; P < .05). There was no difference in surgical time between the 2 groups. None of the sensitivity analyses performed affected the original analysis outcome. CONCLUSION: This study shows a modest but significant reduction in length of stay and lower rate of discharge to a rehabilitation center in the comparator device group.